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Not So Different: Steven Lucio Discusses BI’s Citizen Petition and the Current Status of Biosimilars
We sat down with Steven Lucio, PharmD, BCPS, senior principal of Pharmacy Solutions for Vizient, to discuss Boehringer Ingelheim's recent citizen's petition to the FDA.
In late 2020, Boehringer Ingelheim (BI) filed a citizen’s petition requesting the FDA to alter its definition of the word “strength” as used in a section of the Biologics Price Competition and Innovation Act (BPCIA). As of right now, the term is used in regard to parenteral solutions and does not allow a biological product to be licensed as a biosimilar or an interchangeable biosimilar if any variation in the volume of inactive drug content exists, even if the amount of active drug content remains consistent with the reference product.
The company argued that the current definition permits originator manufacturers to continue to develop follow-on products by only slightly changing the formulation in order to prevent biosimilar competitors from obtaining market share and goes against the goals of the BPCIA and the intention of Congress when the BPCIA was passed.
We spoke with Steven Lucio, PharmD, BCPS, vice president of Pharmacy Solutions for Vizient, to discuss his thoughts on BI’s petition and what needs to be done to advance biosimilar uptake in the United States.
To learn more about BI’s citizen petition, click here.
To hear more from Steven Lucio, PharmD, BCPS, click here.
To learn more about Vizient, click here.
Biosimilars Gastroenterology Roundup for November 2024—Podcast Edition
December 1st 2024On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.
Improving Biosimilar Access Through Global Regulatory Convergence
January 15th 2025Achieving global regulatory harmonization for biosimilar vaccines and immunotherapies is essential to improving market access, reducing costs, and enhancing patient outcomes by streamlining approval processes, fostering international collaboration, and addressing regulatory disparities.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
